Non Small Cell Lung CancerNCT03840408
Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
A study testing Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation and Surgery in people with Non Small Cell Lung Cancer, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Lung cancer is the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery. Mitochondria-targeted system therapy combined with radiofrequency ablation could be an alternative treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,753 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2019to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.
- Patients with single nodule.
- Before IIB period according to the eighth edition of the TNM staging period.
- No mediastinal lymph node metastasis.
- No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
- Eastern Cooperative Oncology Group performance status of 0 to 1
- Sufficient organ functions
Who cannot join
- Active bacterial or fungous infection.
- Simultaneous or metachronous (within the past 5 years) double cancers.
- Patients with contraindications to radiofrequency ablation and inability to complete treatment;
- Women during pregnancy or breast-feeding.
- Uncontrollable diabetes mellitus.
- Patients with severe heart, lung, kidney disease or other systemic diseases who have been judged to have a severe impact on survival or who are pre-assessed to be unable to tolerate thoracoscopic surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, +86200072
Ming Li, M.D., +8613524348108, mlid163@163.com
About this study
Official title: Prospective Clinical Study of Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
Lung cancer is the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery. Mitochondria-targeted system therapy combined with radiofrequency ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to determine if the efficacy of mitochondria-targeted system therapy combined with radiofrequency ablation is comparable to that of standard surgical interventions for patients with non-small cell lung cancer.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation, Surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitochondria-targeted System Therapy Combined With Radiofrequency AblationOther
Patients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites
SurgeryProcedure or surgery
Patients will be treated with surgery
| Study group | Role | What they receive |
|---|---|---|
| Mitochondrial therapy with radiofrequency ablation | Experimental | Not described Receives: Other: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation |
| Surgery | Active comparator | Not described Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Measured: From the date of randomization until the date of first documented progression，assessed up to 60 months
Secondary outcomes (1)
Overall survival
Measured: From the date of randomization until the date of death from any cause，assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start31 Jan 2019
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,753 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Li, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840408
- Sponsor's protocol ID
- Shanghai
- Status last verified
- Feb 2019
- First submitted
- 12 Feb 2019
- Last updated
- 20 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation for Early-stage Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03840408
- Acronym / sponsor ID
- Shanghai
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,753 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is the leading cause of cancer related mortality. Among them, non small cell lung cancer accounts for 85%. Only part of patients could be treated with radical surgery. Mitochondria-targeted system therapy combined with radiofrequency ablation could be an alternative treatment. Small sample clinical cases verified that this therapy could be an efficacy and safe treatment in a short period. The primary aim of this trial is to determine if the efficacy of mitochondria-targeted system therapy combined with radiofrequency ablation is comparable to that of standard surgical interventions for patients with non-small cell lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitochondrial therapy with radiofrequency ablation | Experimental | Other: Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation |
| Surgery | Active comparator | Procedure: Surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient can understand and voluntarily join the study, sign the informed consent form, and the compliance is good.
- Patients with single nodule.
- Before IIB period according to the eighth edition of the TNM staging period.
- No mediastinal lymph node metastasis.
- No prior anticancer treatments including surgery, radiation,chemotherapy or local treatments.
Key exclusion criteria (6 listed)
- Active bacterial or fungous infection.
- Simultaneous or metachronous (within the past 5 years) double cancers.
- Patients with contraindications to radiofrequency ablation and inability to complete treatment;
- Women during pregnancy or breast-feeding.
- Uncontrollable diabetes mellitus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitochondria-targeted System Therapy Combined With Radiofrequency AblationPatients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites | Other | Mitochondrial therapy with radiofrequency ablation |
| SurgeryPatients will be treated with surgery | Procedure or surgery | Surgery |
Primary outcome
Disease-free survival
Time frame: From the date of randomization until the date of first documented progression，assessed up to 60 months
1 secondary outcome
Overall survival
Time frame: From the date of randomization until the date of death from any cause，assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation and Surgery in people with Non Small Cell Lung Cancer, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LiH Fan, M.D. (+8613661599588, fanlih@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: From the date of randomization until the date of first documented progression，assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.